The FDA has ordered the U.S. facility that ruined millions of doses of Johnson & Johnson’s COVID-19 vaccine to halt manufacturing while the agency investigates last month’s ingredient mix-up.
Emergent BioSolutions, the company that owns and runs the Baltimore plant that had been making the J&J vaccine, said in a regulatory filing that the FDA requested a pause on April 16 in production of new drug substance for the shot pending completion of the inspection.
Johnson & Johnson said it would work with Emergent and the FDA to address any findings at the end of the inspection.
J&J was put in charge of manufacturing at the plant in early April by the U.S. government after it disclosed the error. That saw ingredients from AstraZeneca’s shot also being produced at the plant at that time contaminated a batch of the J&J vaccine.
The request to pause manufacturing is the latest setback to J&J’s vaccine, whose use has been halted by U.S. regulators as they review reports of rare but serious brain blood clots in people who took the one-dose shot.
U.S. health officials are expected to issue updated guidance on who should use the vaccine on Friday, but the hold on the Baltimore plant could mean further delays before the U.S. supply of the one-dose vaccine ramps back up.
FDA officials have ordered production of Johnson & Johnson’s vaccine to be halted at Emergent BioSolution’s Baltimore plant while it investigates an ingredient mix-up that ruined 15 million doses of the shot
J&J was put in charge of manufacturing at the plant (pictured) in early April by the U.S. government after it disclosed the error in which ingredients from AstraZeneca’s shot also being produced at the plant at that time contaminated a batch of the J&J vaccine
The Emergent BioSolutions facility had been seeking authorization from the FDA for the J&J vaccine when the error occurred.
J&J has authorization to make doses in the Netherlands and finish them in the U.S. a a plant run by Catalent.
‘At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries,’ J&J said in a statement.
The company has previously said it would deliver 100 million doses of its vaccine to the United States during the first half of 2021 and has so far delivered about 18 million.
J&J said in a statement it was focused on securing emergency use authorization for the Emergent plant.
Emergent said on Monday in a regulatory filing that the FDA started its review on April 12.
The company said it would quarantine existing material manufactured at the Baltimore facility until the review is complete.
‘We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes,’ Emergent said in an emailed statement.
In March, J&J said it had found a problem with a batch of the drug substance for its COVID-19 vaccine being produced by Emergent.
J&J did not say how many vaccine doses the spoiled batch would have produced, but the New York Times, without citing a source, reported that about 15 million doses were ruined.
The Times described the error as the result of an ingredient intended for AstraZeneca’s vaccine being swapped accidentally into the solution J&J’s vaccine.
Issues at the Emergent facility are not thought to be at all related to the investigations into blood clots among people who received J&J’s vaccine.
But the combined effects of the delays from the inspection and from the trial pause could have ripples for the overall U.S. vaccine supply.
Even with zero doses of J&J’s shot allocated to U.S. states, the national supply shipped out this week will still increase compared to last.
Overall, states will get 17,580,0000 doses this week. Pfizer will ship about two million more doses than it did last week, and Moderna will provide about 157,000 more doses compared to the week of April 12.
But several states said their supply will fall after. California said its allocated doses fell by a third last week and it was expecting to see another four percent drop in its shipments this week.
And a secondary concern looms: that pauses on both the manufacturing and the use of J&J’s vaccine will fuel hesitancy in the U.S. and abroad, especially in poorer countries that have been counting on the cheaper, easier to store vaccine for their rollouts.